Implantable tinnitus therapy

ABSTRACT

Presented herein are techniques for providing tinnitus relief to recipients via an implantable arrangement. In accordance with embodiments presented herein, an implantable medical device, such as implantable tinnitus therapy device, auditory/hearing prosthesis, etc., comprises one or more implantable sensors configured to be implanted in a recipient. The one or more implantable sensors are configured to detect body noises of the recipient. The implantable medical device is configured to classify/categorize the one or more body noises and set, select, or otherwise determine a tinnitus therapy for the recipient based on the classification of the one or more body noises.

BACKGROUND Field of the Invention

The present invention relates generally to tinnitus therapy with animplantable medical device.

Related Art

Medical devices have provided a wide range of therapeutic benefits torecipients over recent decades. Medical devices can include internal orimplantable components/devices, external or wearable components/devices,or combinations thereof (e.g., a device having an external componentcommunicating with an implantable component). Medical devices, such astraditional hearing aids, partially or fully-implantable hearingprostheses (e.g., bone conduction devices, mechanical stimulators,cochlear implants, etc.), pacemakers, defibrillators, functionalelectrical stimulation devices, and other medical devices, have beensuccessful in performing lifesaving and/or lifestyle enhancementfunctions and/or recipient monitoring for a number of years.

The types of medical devices and the ranges of functions performedthereby have increased over the years. For example, many medicaldevices, sometimes referred to as “implantable medical devices,” nowoften include one or more instruments, apparatus, sensors, processors,controllers or other functional mechanical or electrical components thatare permanently or temporarily implanted in a recipient. Thesefunctional devices are typically used to diagnose, prevent, monitor,treat, or manage a disease/injury or symptom thereof, or to investigate,replace or modify the anatomy or a physiological process. Many of thesefunctional devices utilize power and/or data received from externaldevices that are part of, or operate in conjunction with, implantablecomponents.

SUMMARY

In one aspect, a method is provided. The method comprises: detectingsignals at one or more implantable sensors configured to be implanted ina recipient, wherein the signals comprise one or more body noises of therecipient; generating, based on the one or more body noises, one or morebody noise classifications; generating tinnitus therapy signals based onthe one or more body noise classifications; and delivering the tinnitustherapy signals to the recipient.

In another aspect, an apparatus is provided. The apparatus comprises:one or more implantable sensors configured to be implanted in arecipient, wherein the one or more implantable sensors are configured todetect one or more body noises of the recipient; a processing unitconfigured to: generate, based on the one or more body noises, one ormore body noise classifications, and generate actuator control signalsbased on the body noise classifications; and an implantable actuatorconfigured to deliver tinnitus therapy signals to the recipient based onthe actuator control signals.

In another aspect, a method is provided. The method comprises: detectingone or more body noises at one or more implantable sensors configured tobe implanted in a recipient; categorizing the one or more body noises;and controlling a tinnitus therapy for the recipient as a function ofthe categorization of the one or more body noises.

In another aspect, one or more non-transitory computer readable storagemedia comprising instructions are provided. The instructions, whenexecuted by a processor, cause the processor to: identify one or morebody noises in signals captured by one or more implantable sensors of animplantable medical device; generate one or more body noiseclassifications based on the one or more body noises; and generatetinnitus therapy control signals based on the one or more body noiseclassifications.

In another aspect, an apparatus is provided. The apparatus comprises: atleast one microphone configured to be implanted in a recipient, whereinthe microphone is configured to detect one or more external acousticsounds; at least one accelerometer configured to be implanted in therecipient, wherein the accelerometer is configured to detect one or morebody noises of the recipient; an implantable actuator rigidly coupled tothe recipient so as to directly or indirectly deliver vibration to acochlea of the recipient; and one or more processors configured toseparately categorize the one or more external acoustic sounds and theone or more body noises and to generate actuator control signals basedon the categorization of the one or more external acoustic sounds andthe one or more body noises, wherein the actuator is configured tovibrate based on the actuator control signals to deliver tinnitustherapy signals to the recipient based on the actuator control signals.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present invention are described herein in conjunctionwith the accompanying drawings, in which:

FIG. 1A is a top view of a totally implantable tinnitus therapy device,in accordance with certain embodiments presented herein;

FIG. 1B is a schematic diagram illustrating the totally implantabletinnitus therapy device of FIG. 1A implanted within the head of arecipient, in accordance with certain embodiments presented herein;

FIG. 1C is a functional block diagram of the totally implantabletinnitus therapy device of FIG. 1A, in accordance with certainembodiments presented herein;

FIG. 1D is a perspective view of an actuator of the totally implantabletinnitus therapy device of FIG. 1A and a fixation system, in accordancewith certain embodiments presented herein;

FIG. 1E is another perspective view of the actuator and fixation systemof FIG. 1D, in accordance with certain embodiments presented herein;

FIG. 2 is a functional block diagram of a processing unit of animplantable tinnitus therapy device, in accordance with certainembodiments presented herein;

FIG. 3 is a schematic diagram illustrating a cochlear implant, inaccordance with certain embodiments presented herein;

FIG. 4 is a high-level flowchart of a method, in accordance with certainembodiments presented herein; and

FIG. 5 is a high-level flowchart of another method, in accordance withcertain embodiments presented herein;

DETAILED DESCRIPTION

Tinnitus is the perception of noise or “ringing” in the ears whichcurrently affects an estimated 30 million people in the United Statesalone. Tinnitus is a common artefact of hearing loss, but can also be asymptom of other underlying conditions, such as ear injuries,circulatory system disorders, etc. Although tinnitus affects can rangefrom mild to severe, almost one-quarter of those with tinnitus describetheir tinnitus as disabling or nearly disabling.

Presented herein are techniques for providing tinnitus relief torecipients via an implantable arrangement. In accordance withembodiments presented herein, an implantable medical device, such asimplantable tinnitus therapy device, auditory/hearing prosthesis, etc.,comprises one or more implantable sensors configured to be implanted ina recipient. The one or more implantable sensors are configured todetect body noises of the recipient. The implantable medical device isconfigured to classify/categorize the one or more body noises and set,select, or otherwise determine a tinnitus therapy for the recipientbased on the classification of the one or more body noises.

Merely for ease of description, the tinnitus therapy techniquespresented herein are primarily described herein with reference to aso-called “stand-alone” implantable tinnitus therapy device, sometimesreferred to herein as a tinnitus therapy device or tinnitus reliefdevice. As used herein, a tinnitus therapy or tinnitus relief device isan implantable medical device having a primary purpose of providingtinnitus therapy/relief to a recipient. However, it is to be appreciatedthat the techniques presented herein can also be incorporated into, orperformed by, a variety of other implantable medical devices. Forexample, the techniques presented herein can be used with other auditoryprostheses, including cochlear implants, bone conduction devices, middleear auditory prostheses, direct acoustic stimulators, auditory brainstimulators), etc. The techniques presented herein can also be used withvestibular devices (e.g., vestibular implants), visual devices (i.e.,bionic eyes), sensors, pacemakers, drug delivery systems,defibrillators, functional electrical stimulation devices, catheters,seizure devices (e.g., devices for monitoring and/or treating epilepticevents), sleep apnea devices, electroporation devices, etc.

FIG. 1A is a top view of an implantable tinnitus therapy device 100, inaccordance with certain embodiments presented herein. FIG. 1B isschematic diagram illustrating the implantable tinnitus therapy device100 of FIG. 1A implanted in a recipient 10, while FIG. 1C is a schematicblock diagram of the implantable tinnitus therapy device 100. For easeof description, FIGS. 1A-1C will be described together.

The implantable tinnitus therapy device 100 of FIGS. 1A-1C comprises asound input unit 102, an implant body 104, an actuator 106, and a coil108, all implanted under the skin/tissue of the recipient 101. The soundinput unit 102 comprises a substantially rigid housing 110, in which atleast two implantable sensors 112 and 114 are disposed/positioned. Theimplantable sensor 112 is more sensitive to external acoustic soundsthan it is to body noises, while implantable sensor 114 is moresensitive to body noises than it is to external acoustic sound signals.That is, the implantable sensor 112 is a “sound” sensor/transducer thatis primarily configured to detect/receive external acoustic sounds(e.g., an implantable microphone), while the implantable sensor 114 is a“vibration” sensor that is primarily configured to detect/receiveinternal body noises (e.g., another implantable microphone or anaccelerometer). The increased sensitivity of the sensor 114 to bodynoise can be due to, for example, the structure of the sensor 114relative to the sensor 112, the implanted position of the sensor 114relative to the sensor 112, etc. For ease of reference, the microphone112 and the accelerometer 114 are sometimes collectively referred toherein as “implantable sensors” 144.

For ease of description, embodiments presented herein will be primarilydescribed with reference to the use of an implantable microphone 112 asthe sound sensor and an accelerometer 114 as the vibration sensor.However, it is to be appreciated that these specific implementations arenon-limiting and that embodiments of the present invention can be usedwith different types of implantable sensors.

The housing 110 is hermetically sealed and includes a diaphragm 116 thatis proximate to the microphone 112. The diaphragm 116 can be unitarywith the housing 116 and/or can be a separate element that is attached(e.g., welded) to the housing 112. The sound input unit 102 isconfigured to be implanted within the recipient 101. In one exampleshown in FIG. 1B, the sound input unit 102 is configured to be implantedwithin the skin/tissue adjacent to the outer ear 103 of the recipient.In this position, the diaphragm 116 is below the skin of the recipientthat is close to the recipient’s ear canal 105. In operation, soundsignals that impinge on the skin adjacent to (i.e., on top of) thediaphragm 116 cause the skin adjacent the diaphragm 116, and thus thediaphragm 116 itself, to be displaced (vibrate) in response to the soundsignals. The displacement of the diaphragm 116 is detected by themicrophone 112. In this way, the microphone 112, although implantedwithin the recipient, is able to detect external acoustic sound signals(external acoustic sounds).

In the example of FIGS. 1A-1C, the implantable microphone 112 and theaccelerometer 114 can each be electrically connected to the implant body104 (e.g., in a separate casing connected to the main implant body 104).Alternatively, the implantable microphone 112 and the accelerometer 114can be integrated in the main implant body 104. In operation, themicrophone 112 and the accelerometer 114 detect input (sound/vibration)signals (e.g., external acoustic sounds and/or body noises) and convertthe detected input signals into electrical signals that are provided tothe processing unit 118 (e.g., via lead 120). As described furtherbelow, the processing unit 118 is configured to identify andclassify/categorize body noises detected by the accelerometer 114 and/ormicrophone 112. The processing unit 118 is configured to generatetinnitus therapy control signals 119 (FIG. 1C) based at least onidentified body noises detected by the accelerometer 114 and/ormicrophone 112. Also as described further below, in certain examples theprocessing unit 118 is further configured to generate the tinnitustherapy control signals based the identified body noises and based on anacoustic environment of the recipient (e.g., based on a classificationof the body noises and based on a classification of acoustic soundsignals detected by the accelerometer 114 and/or microphone 112).

In the example of FIG. 1B, the processing unit 118 comprises at leastone processor 122 and memory 124. The memory 124 includes tinnitustherapy logic 126 that, when executed by the at least one processor 122,cause the at least one processor 122 to perform the tinnitus therapyoperations described herein (e.g., identify one or more body noises insignals captured by the implantable sensors, classify the one or morebody noises, and generate tinnitus therapy control signals based atleast on identified body noises). Memory 124 can comprise any suitablevolatile or non-volatile computer readable storage media including, forexample, random access memory (RAM), cache memory, persistent storage(e.g., semiconductor storage device, read-only memory (ROM), erasableprogrammable read-only memory (EPROM), flash memory, etc.), or any othercomputer readable storage media that is capable of storing programinstructions or digital information. The processing unit 118 can beimplemented, for example, on one or more printed circuit boards (PCBs).

It is to be appreciated that the arrangement for processing unit 118 inFIG. 1C is merely illustrative and that the tinnitus therapy techniquespresented herein can be implemented with a number of differentprocessing arrangements. For example, the tinnitus therapy techniquesherein can be implemented with processing units formed by any of, or acombination of, one or more processors (e.g., one or more Digital SignalProcessors (DSPs), one or more uC cores, etc.), firmware, software, etc.arranged to perform, for example, the operations described herein.

As shown, the implant body 114 includes a hermetically sealed housing128 in which the processing unit 118 is disposed. Also disposed in thehousing 128 is a power source (e.g., rechargeable battery) 130 and aradio-frequency (RF) interface circuitry 132. Electrically connected tothe RF interface circuitry 132 is the implantable coil 108, which isdisposed outside of the housing 128. Implantable coil 108 is typically awire antenna coil comprised of multiple turns of electrically insulatedsingle-strand or multi-strand platinum or gold wire. The electricalinsulation of implantable coil 108 is provided by a flexible molding(e.g., silicone molding) 109 (FIG. 1A). In general, the implantable coil108 and the RF interface circuitry 132 enable the receipt of power anddata from an external device (not shown in FIGS. 1A-1C) and,potentially, the transfer of data to an external device. However, it isto be appreciated that various types of energy transfer, such asinfrared (IR), electromagnetic, capacitive and inductive transfer, canbe used to transfer power and/or data from an external device and, assuch, FIG. 1B illustrates only one example arrangement.

In certain example, the external device can comprise an off-the-ear(OTE) unit that is configured to send data, and potentially power, tothe implantable tinnitus therapy device 100. In general, an OTE unit isa component having a generally cylindrical shape and which is configuredto be magnetically coupled to the recipient’s head. The OTE unit alsoincludes an integrated external coil that is configured to beinductively coupled to the implantable coil 108. In alternativeexamples, the external device can comprise a behind-the-ear (BTE) unitor a micro-BTE unit, configured to be worn adjacent to the recipient’souter ear. In general, a BTE unit comprises a housing that is shaped tobe worn on the outer ear of the recipient and is connected to a separateexternal coil configured to be inductively coupled to the implantablecoil 108.

It is to be appreciated that OTE units and BTE units are merelyillustrative of the external devices that can operate with animplantable tinnitus therapy device, such as device 100, in accordancewith embodiments presented herein. Alternative external devices can belocated in the recipient’s ear canal, a body-worn, a consumer electronicdevice (e.g., mobile phone communication with implantable tinnitustherapy device via a wireless link), etc. For example, in certainembodiments, the implant body 104 can also include a short-rangewireless interface for communication with external devices. Theshort-range wireless interface can be, for example, as Bluetooth®interface, Bluetooth® Low Energy (BLE) interface, or other interfacemaking use of any number of standard or proprietary protocols.Bluetooth® is a registered trademark owned by the Bluetooth® SIG.

Returning to the example of FIGS. 1A-1C, as noted above, the processingunit 118 generates tinnitus therapy control signals 119. The tinnitustherapy control signals 119 are provided to the actuator 106 (e.g., vialead 134) for use in delivering tinnitus therapy signals (tinnitustherapy) to the recipient. In FIG. 1C, the tinnitus therapy signalsdelivered to the recipient are represented by arrow 121.

In the example of FIG. 1B, the actuator 106 delivers the tinnitustherapy signals 121 to the recipient via the ossicular chain (ossicles)136 (i.e., the bones of the middle ear, which comprise the malleus, theincus and the stapes). The ossicles 136 are positioned in the middle earcavity 113 and are mechanically coupled between the tympanic membrane113 and the oval window (not shown) of cochlea 138. In natural hearing,the ossicles 136 serve to filter and amplify sound waves received viathe recipient’s ear canal 111, causing oval window to articulate(vibrate) in response to the vibration of tympanic membrane 113. Thisvibration of the oval window sets up waves of fluid motion of theperilymph within cochlea 138. Such fluid motion, in turn, activates tinyhair cells (not shown) inside of cochlea 138. Activation of the haircells causes appropriate nerve impulses to be generated and transferredthrough the spiral ganglion cells (not shown) and auditory nerve (notshown) to the brain (also not shown), where they are perceived as sound.

As shown in FIG. 1B, the actuator 106 is configured to be implanted inthe recipient so as to impart motion to (e.g., vibrate) the ossicles136. In FIG. 1B, the actuator 106 attached to the bone 115 of therecipient via a fixation system 142 (also shown in more detail in FIGS.1D and 1E). In addition, the actuator 106 is mechanically coupled to theossicles 136 (e.g., the incus) via a coupling member 140, which can bepart of the actuator 106 and/or a separate element attached to theactuator.

In operation, the actuator 106 is configured to generate vibration(vibration signals 121) based on the tinnitus therapy control signals119 received from the processing unit 118. Since, as noted, the ossicles136 are coupled to the oval window (not shown) of cochlea 138, vibrationimparted to the ossicles 136 by the actuator 106 will, in turn, causeoval window to articulate (vibrate) in response thereto. Similar to thecase with normal hearing, this vibration of the oval window sets upwaves of fluid motion of the perilymph within cochlea 138 which, inturn, activates the hair cells inside of the cochlea 138. Activation ofthe hair cells causes appropriate nerve impulses to be generated andtransferred through the spiral ganglion cells (not shown) and auditorynerve (not shown) to the brain (also not shown), where they areperceived as sounds that, as described below, provide relief of tinnitussymptoms experienced by the recipient.

As noted, FIG. 1B illustrates an arrangement in which the actuator 106is mechanically coupled to the ossicles 136 via coupling member 140. Incertain embodiments, such as a stand-alone tinnitus therapy deviceembodiment, the coupling between actuator 106 and the ossicles 136 issufficiently rigid so as to enable the delivery of the tinnitus therapysignals to the ossicles 136, but is also configured so as to have no oronly minimal negative effects on the recipient’s natural hearingcapabilities, thereby making the actuator 106 and coupling member 140useable for recipient’s with normal hearing (e.g., no or minimal hearingloss).

It is to be appreciated that the arrangement shown in FIG. 1B in whichthe actuator 106 is mechanically coupled to the ossicles 136 is merelyillustrative and that the tinnitus therapy techniques presented hereincan be used with different mechanical stimulation arrangements. Forexample, in alternative embodiments, the actuator 106 can be coupleddirectly to the oval window, another opening in the cochlea 138 (e.g., acochleostomy or the round window), an opening in the recipient’ssemicircular canals, etc.

FIG. 2 is a functional block diagram illustrating further details of thetinnitus therapy techniques presented herein. For ease of description,FIG. 2 will be described with reference to the arrangement shown inFIGS. 1A-1E.

In particular, shown in FIG. 2 is the sound input unit 102, the actuator106, and a functional representation of the processing unit 118. In thisexample, the processing unit 118 is represented as a plurality offunctional modules, including body noise and environment analysis module150, control module 152, tinnitus map module 154, learn and updatemodule 156, remote control module 158, and tinnitus signal generator160. It is to be appreciated that the functional arrangement shown inFIG. 2 is merely illustrative and does not require or imply any specificstructural arrangements. Thee various functional modules shown in FIG. 2can be implemented in any combination of hardware, software, firmware,etc.

Returning to the example of FIG. 2 , the sound input unit 102 includesimplantable sensors 144 (e.g., microphone 112 and accelerometer 114),which are configured to detect/receive external acoustic sound signalsand/or body noises. As used herein, external acoustic sound signals(external acoustic sounds) are sound signals (sounds) that originatefrom outside of the recipient’s body. In contrast, body noises aresounds induced by the body (i.e., originating inside the body of therecipient) that are propagated primarily as vibration, such asbreathing, scratching, rubbing, noises associated with the movement ofthe head, chewing, etc. Own voice (OV) (i.e., when the recipient speaks)is a particular case of body noise since the sound is transmitted boththrough air conduction and bone conduction (i.e., skull vibrations). Incertain own voice instances, most of these sound propagates through theskull bones and produce accelerations at the implantable microphone.That is, in general, body noises that can be characterized as anacceleration coming from the body (or the recipient’s own voice), andcaptured by the implantable sensors 144.

The sounds detected by the implantable sensors (either external acousticsound signals or body noises) are converted into electrical inputsignals, which are represented in FIG. 2 by arrow 149. As shown, thesound input unit 102 provides the electrical input signals 149 to thebody noise and environment analysis module 150. The body noise andenvironment analysis module 150 can be configured to perform a number ofoperations based on the electrical input signals 149.

In particular, the body noise and environment analysis module 150 isconfigured to identify and “classify” or “categorize” the body noise(s)present in the electrical input signals 149 provided by the implantablesensors 144. That is, using the electrical input signals 149, the bodynoise and environment analysis module 150 is configured to identify anybody noises that are present and evaluate/analyze the received bodynoises to determine the class/category/ of the body noises.

A classification of the body noise(s), referred to herein as a “bodynoise classification,” by the body noise and environment analysis module150 can take any of a number of different forms. For example, the bodynoise classification can indicate a current estimated activity orbehavior of the recipient, such as “sleeping,” “snoring,” “eating,”“chewing,” “speaking” (i.e., own-voice detection), etc. (i.e., a bodynoise-based activity classification). The body noise classifications canalso indicate current background body noises, including “breathing,”“heartbeat,” “swallowing,” etc. In addition, the body noiseclassifications can indicate emotional reactions (emotions) of therecipient (e.g., stress, anxiety, etc.). The body noise classificationscan also provide qualitative indications of the recipient’s currentestimated activities or background body noises, such as “low heartrate,”“deep breathing,” “shallow breathing,” “deep sleep,” etc.

In accordance with certain embodiments presented herein, the body noiseand environment analysis module 150 can make multiple simultaneousclassifications of a recipient’s body noise(s) (i.e., simultaneouslyclassify the same electrical input signals generated based on the samesignals captured within a time period in different manners). Forexample, the body noise and environment analysis module 150 cansimultaneously classify body noise(s) as “low heartrate” and “deepbreathing.”

In addition to generating body noise classifications, the body noise andenvironment analysis module 150 can also be configured to use theelectrical input signals 149 to “classify” or “categorize” the ambientsound environment of the tinnitus therapy device 100 (i.e., classify theexternal acoustic sounds detected by the implantable sensors 144). Theclassification of the ambient environment, sometimes referred to hereinas an “environment classification,” can include, but are not limited to,“Speech” (e.g., the sound signals include primarily speech signals),“Noise” (e.g., the sound signals include primarily noise signals),“Speech+Noise” (e.g., both speech and noise are present in the soundsignals), “Wind” (e.g., e.g., the sound signals include primarily windsignals), “Music” (e.g., the sound signals include primarily musicsignals), and “Quiet” (e.g., the sound signals include minimal speech ornoise signals). It is to be appreciated that these specificclassifications are merely illustrative and that the ambient environmentcan also or alternatively be classified in other manners, such as a“Soft,” a “Moderate,” or “Loud,” environment, etc. In certainembodiments, the body noise and environment analysis module 150 can alsoestimate the signal-to-noise ratio (SNR) of the external sound signals.

In one example, the body noise and environment analysis module 150generates sound classification information/data 151, whichincludes/indicates at least the body noise classification(s) (i.e., theresults of the analysis of the body noise(s) detected by the implantablesensors 144). As noted, in certain embodiments, the sound classificationdata 151 can also include the environment classification (i.e., theresults of the analysis of the external sound signals detected by theimplantable sensors 144) and, potentially, the SNR of the external soundsignals. As such, in one illustrative example, the sound classificationinformation/data 151 can indicate: “Quiet” (environmentalclassification), “low heartrate” (first body noise classification), and“deep breathing” (second body noise classification). In anotherillustrative example, the sound classification information/data 151 canindicate: “Loud” (environmental classification), “speaking” (first bodynoise classification), and “shallow breathing” (second body noiseclassification). These combinations of classifications are merelyillustrative.

As noted above, in addition to the body noise and environment analysismodule 150, the processing unit 118 also functionally includes a controlmodule 152. The control module 152 is configured to use the soundclassification data 151 to select, set, or otherwise determine atinnitus therapy for the recipient, as a function of the recipient’sbody noises (e.g., determine an appropriate tinnitus therapy for therecipient, given the recipient’s current ambient environmentclassification(s) and body noise classification(s)). Stated differently,the tinnitus therapy that is to be provided to the recipient isspecifically determined based at least on one or more classifications ofthe recipient’s body noises. As noted, in certain embodiments, thetinnitus therapy can also be determined based on one or moreclassifications of the ambient sound environment of the recipient and/oran SNR of the external acoustic sound signals.

In accordance with embodiments presented herein, the tinnitus therapyincludes the delivery of stimulation signals (stimulation) to therecipient. These stimulation signals, sometimes referred to herein as“tinnitus therapy signals” or “tinnitus relief signals,” can have anumber of different forms and underlying objectives. For example, incertain embodiments, the tinnitus therapy signals can be masking signalsthat are configured to mask./cover the recipient’s tinnitus symptoms(e.g., expose the recipient to sounds/noises at a loud enough volumethat it partially or completely covers the sound of their tinnitus). Inother embodiments, the tinnitus therapy signals can be distractionsignals that are configured to divert the recipient’s attention from thesound of tinnitus. In other embodiments, the tinnitus therapy signalscan be habituation signals that are configured to assist the recipient’sbrain in reclassifying tinnitus as an unimportant sound that should canbe consciously ignored. In still other embodiments, the tinnitus therapysignals can be neuromodulation signals that are configured to minimizethe neural hyperactivity thought to be the underlying cause of tinnitus.In certain embodiments, the tinnitus therapy signals can be anycombination of masking signals, distraction signals, habituationsignals, and/or neuromodulation signals.

As noted, in the example of FIGS. 1A-1D and FIG. 2 , the implantabletinnitus therapy device 100 includes an actuator 106 coupled to therecipient’s ossicles 136. As such, in these examples, the tinnitustherapy signals, whether configured for masking, distraction,habituation, and/or neuromodulation purposes, are mechanical stimulationsignals configured to cause motion of the fluid in the recipient’scochlea 138 (FIG. 1B). Shown in FIG. 2 is a tinnitus signal generator160 that is configured to generate tinnitus therapy control signals(e.g., actuator control signals) 119 that drive the actuator 106 in amanner determined by the control module 152. That is, the tinnitustherapy control signals 119 are configured to cause the actuator 106 tovibrate in a selected manner. The tinnitus therapy signals delivered tothe recipient are schematically represented in FIG. 2 by arrow 121.

The tinnitus therapy control signals 119 generated by the tinnitussignal generator 160 can dictate a number of different parameters forthe tinnitus therapy signals 121. For example, the tinnitus therapycontrol signals 119 can be such that the tinnitus therapy signals 121will be pure tone signals, multi tone signals, broadband noise,narrowband noise, low-pass filtered signals, high-pass filtered signals,band-pass filter signals, predetermined recordings, etc. The tinnitustherapy control signals 119 can also set modulations in the tinnitustherapy signals 121, transitions, etc. It is to be appreciated thatthese specific parameters are merely illustrative and that the tinnitustherapy signals 121 can have any of a number of different forms.

As described elsewhere herein, it is to be appreciated that use ofmechanical stimulation signals for tinnitus therapy is merelyillustrative of one technique that can be used in accordance withembodiments presented herein. In particular, in alternativearrangements, the tinnitus therapy signals can be electrical stimulationsignals, mechanical stimulation signals delivered at a differentlocation, electro-mechanical stimulation signals (e.g., electricalsignals and mechanical signals delivered simultaneously or in closetemporal proximity to one another), acoustic stimulation signals,electro-acoustic stimulation signals (e.g., electrical signals andacoustic signals delivered simultaneously or in close temporal proximityto one another), etc.

As noted above, the control module 152 is configured to determine thetinnitus therapy based on the sound classification data 151, whichincludes at least the body noise classification and, in certainembodiments, the environmental classification. In the specific exampleof FIG. 2 , the processing unit 118 includes a tinnitus map module 154that is configured to store a plurality of different tinnitus therapymaps 155. In general, each of the tinnitus therapy maps 155 is aset/collection of parameters that, when selected and used by the controlmodule 152 and/or tinnitus signal generator 160, control the generationof the tinnitus therapy signals (e.g., used to generate tinnitus therapycontrol signals 119). The parameters can control the sound type (e.g.,white noise, wave sounds, rain sounds, etc.), fluctuation rate, sound ormasker level settings, on/off, pitch settings transition time settings,etc. In operation, different tinnitus therapy maps 155 can be created(e.g., by the software, an audiologist/clinician, through artificialintelligence, etc.) for different situations (i.e., differentcombinations of body noise classification(s) and environmentalclassifications). In operation, there will be maps for differenttherapies, such as specific maps for masking, specific maps fordistraction, specific maps for habituation, specific maps forretraining, etc.

In the example of FIG. 2 , the control module 152 is configured toanalyze the sound classification data 151 (e.g., analyze the one or morebody noise classifications and environmental classifications) and selectone of the tinnitus therapy maps 155 for use in generating the tinnitustherapy signals delivered to the recipient. That is, in operation, thecontrol module 152 is configured to select (e.g., using a neuralnetwork, artificial intelligence or machine learning engine, etc.) themost appropriate tinnitus therapy map for the recipient in therecipient’s current “sound situation,” where the current sound situationincludes the recipient’s currently present body noises and theattributes of the ambient environment. In accordance with embodimentspresented herein, the recipient’s current sound situation” ischaracterized by the one or more body noise classifications and, incertain embodiments, the one or more classifications of the ambientenvironment.

In certain examples, a selected tinnitus therapy map can be used toprovide tinnitus therapy until the sound classification data 151 changesin manner that causes the control module 152 to select a differenttinnitus therapy map. Once another tinnitus therapy map 155 is selectedfor use (for activation), the control module 152 will manage thetransition between the maps to avoid unintended issues (e.g., annoyanceto the recipient). For example, the device can select a map forretraining when the sound classification data 151 indicates a “Quiet”environment and “low breathing,” which can mean that the recipient isrelaxed and will be more receptive to that therapy. If the soundclassification data 151 subsequently indicates a moderate musicenvironment, then the device can switch to a masking therapy with lowband pass modulated noise to not interfere with the music. If the soundclassification data 151 subsequently indicates a “very low heart rate,”“Quiet” environment,” and “very low breathing,” then the device candetermine that the recipient is asleep and the tinnitus therapy can betemporarily paused to save power (e.g., stop tinnitus therapyautomatically when the recipient has fallen asleep).

In another example, if the sound classification data 151 subsequentlyindicates “anxiety,” the control module 152 can transition from, forexample, retraining to relief therapy or masking instead. The detectionof emotional reactions, in particular, can be used as a check todetermine if a particular therapy is working by looking at, for example,heart rate or blood pressure changes when a particular therapy isactivated. For example, the system can determine the recipient’semotional reactions to one or more tinnitus therapy signals. Theseemotional reactions can be stored and used as a part of an automatedadaption process to adjust tinnitus therapy signals delivered to therecipient upon subsequent detection of the one or more body noiseclassifications.

As noted, FIG. 2 illustrates an example embodiment in which a pluralityof predetermined tinnitus therapy maps 155 are stored and subsequentlyselected for use by the control module 152 and/or tinnitus signalgenerator 160. It is to be appreciated that a specific tinnitus therapymap can be selected in a number of different manners and that theselection can be based on information/data other than the soundclassification data 151.

For example, initially, the control module 152 is programmed to select aspecific tinnitus therapy map with specific sound classification data151 (i.e., programmed to select a specific map for specific combinationsof one or more body noise classifications and environmentalclassifications). In certain embodiments, the initial programming ofcontrol module 152 can be based on normative data for a population ofdifferent recipients. The initial programming of control module 152 toselect a specific tinnitus therapy map can also or alternatively bebased on predetermined selection settings that are set/determined forthe recipient during a fitting session (e.g., a clinician directedsession, a remote care session, etc.). That is, in certain embodiments,the initial programming of control module 152 is based preferences ofthe recipient, sometimes referred to herein as recipient-specificfitting data.

As noted above, the processing unit 118 also comprises a remote controlmodule 158 and a learn and update module 156. The remote control module158 and the learn and update module 156 are configured to update/adjust,over time, what tinnitus therapy map is selected by the control module152 based, for example, in recipient preferences.

More specifically, the remote control module 158 is configured toreceive recipient requests to change the tinnitus therapy. Theserecipient setting requests, which can be received wirelessly from aremote control device, external component, mobile application, etc.,indicate the changes that the recipient wants to make some change to thetinnitus therapy (e.g., increase volume, change noise type, selectdifferent tinnitus relief map, etc.). The recipient’s requested changescan be acted upon by the control module 152 to adjust, in real-time, theapplied tinnitus therapy (i.e., change parameters of the tinnitustherapy signals 121 being delivered to the recipient).

In addition to being acted upon by the control module 152, recipient’srequested changes are also provided to the learn and update module 156.The learn and update module 156 also has knowledge of body noiseclassification(s) and the environmental classifications(s) (e.g., hasaccess to the sound classification data 151) and has knowledge of whattinnitus relief settings were being utilized (i.e., which tinnitustherapy map 155 was active) when the recipient requested the tinnitussetting changes. With this information, the learn and update module 156is configured to implement an automated learning or adaption process tolearn what tinnitus relief settings are preferred by the recipient inthe presence of certain body noise classification(s) and environmentalclassifications(s).

The recipient preferences can be logged, over time, and analyzedrelative to the body noise classification(s) and environmentalclassifications(s), again over time, and used to learn about therecipient’s preferences and eventually adapt operation of the deviceaccording to the recipient’s preferences (e.g., learn the recipientpreferences and smoothly adapt the tinnitus relief therapy over thelong-term based on the automated learning process). For example, thelearn and update module 156 is configured to update the tinnitus therapymaps 155 and/or update operation of the control module 156 based on theautomated learning process so that the recipient setting preference, inthe presence of certain body noise classification(s) and environmentalclassification(s), is taken into consideration in the future (e.g.,refine which map is selected for given body noise classifications). Inother words, the learn and update module 156 is configured toautomatically adjust operation of the processing unit 118 based onrecipient preferences received during delivery of tinnitus therapy. Thisautomated learning process can, for example, reduce the number of visitsby the recipient to a clinic to adjust operation of the device. Datalogging of the body noise classification(s) and environmentalclassification(s) and recipient interaction events can be saved andused, for example, by a clinician to evaluate the therapy progression ofthe recipient.

In certain embodiments, the learn and update module 156 will monitor thedecision from the control module 152 (i.e., which map is selected) andany user inputs to update and/or create new maps based on eventsequences. For instance, after some weeks, the recipient can feel that amasker level applied in a specific environment is too loud and,accordingly, will manually reduce the signal level (via user inputsreceived at the remote control module 158). As such, the implantabletinnitus therapy device 100 will automatically know what parameters needto be changed (according to the recipient preferences) and in whichsituation those changes should be made.

In addition, the learn and update module 156 can track the time spent insome therapy and make adjusts accordingly (e.g., decreasing the maskinglevel or time in the long term). That is, the learn and update module156 can determine and log (track and store) the attributes of tinnitustherapy signals delivered to the recipient over a period of time (e.g.,time spent in particular therapies, characteristics of the particulartherapies delivered to the recipient, etc.). This information can thenbe used as part of an automated adaption process to adjust tinnitustherapy signals delivered to the recipient upon subsequent detection ofthe one or more body noise classifications (e.g., adjust future therapybased on based on a time spent delivering tinnitus therapy signals tothe recipient with particular attributes).

In certain examples, the learn and update module 156 can be implementedvia a mobile/remote application implemented at an external device (e.g.,mobile phone) in wireless communication with the implantable tinnitustherapy device 100. In such examples, the mobile application can obtainthe logged data and a machine learning module in the application canupdate the maps and tinnitus control logic according to the recipient’spreferences.

As noted, FIG. 2 illustrates an example embodiment in which a pluralityof predetermined tinnitus therapy maps 155 are stored and subsequentlyselected for use by the control module 152 and/or tinnitus signalgenerator 160. It is to be appreciated that embodiments that select fromamong a plurality of predetermined tinnitus therapy maps 155 is merelyillustrative and that other arrangements are possible. For example, inan alternative embodiment, the control module 152 or another entity canbe configured to generate a selected tinnitus therapy map dynamically(e.g., in real-time) based on the sound classification data 151. Inthese embodiments, the selected tinnitus therapy map can be dynamicallygenerated based on an analysis of logged recipient preferences, asdescribed above.

As noted, FIGS. 1A-1E and 2 illustrate aspects of a stand-aloneimplantable tinnitus therapy device 100, sometimes referred to herein asan “invisible” acoustic tinnitus device. A stand-alone implantabletinnitus therapy device can be advantageous in that no external devicesare required, which makes the device aesthetically pleasing,comfortable, and enables the recipient’s ear canal to remain open fornatural hearing. The stand-alone implantable tinnitus therapy devicealso enables around-the-clock therapy regimes, as desired, whileutilizing adaptive learning of sound therapy adjustment to personalizeoperation of the device for the specific recipient. A stand-aloneimplantable tinnitus therapy device that is configured to stimulate theear without introducing hearing loss (middle ear or bone) in aninvisible manner with an implantable microphone can also function as apathway to evolve into a hearing aid or other implantable device in thefuture (e.g., the implantable tinnitus therapy device can be a steppingstone to a middle ear implant, then to a cochlear implant).

As described elsewhere herein, the tinnitus therapy techniques presentedherein are not limited to stand-alone implantable tinnitus therapydevices, but instead can also or alternatively be incorporated as partof an auditory prosthesis, such as a cochlear implant, bone conductiondevice, middle ear auditory prosthesis, direct acoustic stimulator,auditory brain stimulator, etc. For example, FIG. 3 is schematic diagramof a “totally implantable cochlear implant” 300, meaning that allcomponents of the cochlear implant are configured to be implanted underskin/tissue of a recipient. Because all components of cochlear implant300 are implantable, the cochlear implant operates, for at least afinite period of time, without the need of an external device. Anexternal device can be used to, for example, charge an internal powersource (battery) of the cochlear implant 300.

The cochlear implant 300 comprises a sound input module 302, an implantbody (main module) 304, a lead region 362, and an elongateintra-cochlear stimulating assembly 364 configured to be at leastpartially implanted in the recipient’s cochlea 338. Stimulating assembly364 includes a plurality of longitudinally spaced intra-cochlearelectrical stimulating contacts (electrodes) 366 that collectively forma contact or electrode array 368 for delivery of electrical stimulation(current) to the recipient’s cochlea.

The implant body 304 comprises a hermetically sealed housing in which aprocessing unit 318, a stimulator unit 370, radio frequency (RF)interface circuitry (not shown in FIG. 3 ), and at least onerechargeable battery (also not shown in FIG. 3 ) are disposed. Thehousing operates as a protective barrier between the electricalcomponents within the housing (e.g., processing unit 318, stimulatorunit 370, etc.) and the recipient’s tissue and bodily fluid. Thestimulating assembly 364 extends through an opening in the recipient’scochlea (e.g., cochleostomy, the round window, etc.) and has a proximalend connected to the stimulator unit via lead region 362 and a hermeticfeedthrough (not shown in FIG. 3 ). Lead region 362 includes a pluralityof conductors (wires) that electrically couple the electrodes 366 to thestimulator unit.

In the example of FIG. 3 , the sound input unit 302 comprises one ormore implantable sensors (e.g., accelerometer and microphone) configuredto receive/detect body noises and external acoustic sound signals(external acoustic sounds). The processing unit 318 in the implant body304 is configured to convert external acoustic sound signals detected atthe sound input unit 302 into stimulation control signals for use instimulating a first ear of a recipient. Stated differently, theprocessing unit 318 is configured to perform sound processing operationsto convert the external acoustic sound signals into stimulation controlsignals that represent electrical stimulation for delivery to therecipient.

As noted, in addition to the processing unit, the implant body 304 alsoincludes a stimulator unit 370. The stimulator unit 370 is configured toutilize the stimulation control signals (generated by the processingunit) to generate electrical stimulation signals that are delivered tothe recipient’s cochlea via one or more electrodes 366 of the electrodearray 368.

In addition to the sound processing operations, the processing unit 318is configured to perform tinnitus therapy operations, as describedelsewhere herein. More specifically, the processing unit 318 isconfigured to configured to identify and classify/categorize body noisesdetected by the implantable sensors in the sound input unit 302 and togenerate tinnitus therapy control signals based at least on theclassification of the body noises. The tinnitus therapy control signalsare provided to the stimulator unit 370 for use in delivering tinnitustherapy signals (tinnitus therapy) to the recipient. In the example ofFIG. 3 , the tinnitus therapy signals delivered to the recipient areelectrical stimulation signals delivered via one or more of theelectrodes 366. In certain examples the processing unit 318 is furtherconfigured to generate the tinnitus therapy control signals based theidentified body noises and based on an acoustic environment of therecipient (e.g., based on a classification of the body noises and basedon a classification of acoustic sound signals detected by theimplantable sensors in the sound input unit 302).

FIG. 4 is a high-level flowchart of a method 480, in accordance withembodiments presented herein. Method 480 begins at 482 where one or moreimplantable sensors, which are configured to be implanted in arecipient, detect signals comprising one or more body noises of therecipient. At 484, one or more body noise classifications are generatedbased on the one or more body noises. At 486, tinnitus therapy signalsare generated based on the one or more body noise classifications and,at 488, the tinnitus therapy signals are delivered to the recipient.

FIG. 5 is a high-level flowchart of a method 590, in accordance withembodiments presented herein. Method 590 begins at 592 where one or moreimplantable sensors configured to be implanted in a recipient detect oneor more body noises. At 594, the one or more body noises are categorizedand, at 596, a tinnitus therapy for the recipient is controlled as afunction of the categorization of the one or more body noises.

It is to be appreciated that the embodiments presented herein are notmutually exclusive and that the various embodiments can be combined withanother in any of a number of different manners.

The invention described and claimed herein is not to be limited in scopeby the specific preferred embodiments herein disclosed, since theseembodiments are intended as illustrations, and not limitations, ofseveral aspects of the invention. Any equivalent embodiments areintended to be within the scope of this invention. Indeed, variousmodifications of the invention in addition to those shown and describedherein will become apparent to those skilled in the art from theforegoing description. Such modifications are also intended to fallwithin the scope of the appended claims.

1. A method, comprising: detecting signals at one or more implantablesensors configured to be implanted in a recipient, wherein the signalscomprise one or more body noises of the recipient; generating, based onthe one or more body noises, one or more body noise classifications;generating tinnitus therapy signals based on the one or more body noiseclassifications; and delivering the tinnitus therapy signals to therecipient.
 2. The method of claim 1, further comprising: detecting, withthe one or more implantable sensors, one or more external acousticsounds with the one or more body noises; generating, based on the one ormore external acoustic sounds, one or more environmentalclassifications; and generating the tinnitus therapy signals based onthe one or more body noise classifications and based on the one or moreenvironmental classifications.
 3. The method of claim 2, whereingenerating the one or more body noise classifications comprises:simultaneously generating two or more different classifications of theone or more body noises.
 4. The method of claim 1, wherein deliveringthe tinnitus therapy signals to the recipient comprises: generating,with an implantable actuator, mechanical vibration signals based on theone or more body noise classifications; and delivering the mechanicalvibration signals to the recipient.
 5. The method of claim 4, whereindelivering the mechanical vibration signals to the recipient, comprises:delivering the mechanical vibrations to an ossicular bone of therecipient.
 6. The method of claim 4, wherein delivering the mechanicalvibration signals to the recipient, comprises: delivering the mechanicalvibration signals to a skull of the recipient.
 7. The method of claim 1,wherein delivering the tinnitus therapy signals to the recipientcomprises: generating electrical stimulation signals based on the one ormore body noise classifications; and delivering the electricalstimulation signals to the recipient via one or more electrodesconfigured to be implanted in the recipient.
 8. The method of claim 1,wherein generating the tinnitus therapy signals based on the one or morebody noise classifications, comprises: selecting, based on the one ormore body noise classifications, a first tinnitus therapy map from amonga plurality of predetermined tinnitus therapy maps.
 9. The method ofclaim 1, wherein the one or more body noise classifications indicate acurrent estimated behavior of the recipient.
 10. The method of claim 1,further comprising: receiving a user input in response to delivery ofthe tinnitus therapy signals to the recipient, wherein the user inputindicatesa recipient adjustment to the tinnitus therapy signals; andadjusting the tinnitus therapy signals based on the user input.
 11. Themethod of claim 10, further comprising: performing an automated adaptionprocess to adjust, based on the user input, future tinnitus therapysignals delivered to the recipient upon subsequent detection of the oneor more body noise classifications.
 12. The method of claim 10, furthercomprising: performing an automated adaption process to adjust tinnitustherapy signals delivered to the recipient upon subsequent detection ofthe one or more body noise classifications based on emotional reactionsof the recipient to one or more tinnitus therapy signals.
 13. The methodof claim 11, further comprising: logging attributes of tinnitus therapysignals delivered to the recipient over a period of time; and performingan automated adaption process to adjust tinnitus therapy signalsdelivered to the recipient upon subsequent detection of the one or morebody noise classifications based on based on a time spent deliveringtinnitus therapy signals to the recipient with particular attributes.14. An apparatus, comprising: one or more implantable sensors configuredto be implanted in a recipient, wherein the one or more implantablesensors are configured to detect one or more body noises of therecipient; a processing unit configured to: generate, based on the oneor more body noises, one or more body noise classifications, andgenerate actuator control signals based on the one or more body noiseclassifications; and an implantable actuator configured to delivertinnitus therapy signals to the recipient based on the actuator controlsignals.
 15. The apparatus of claim 14, wherein the one or moreimplantable sensors are configured to detect one or more externalacoustic sounds with the one or more body noises, and wherein theprocessing unit is configured to: generate, based on the one or moreexternal acoustic sounds, one or more environmental classifications; andgenerating the actuator control signals based on the one or more bodynoise classifications and based on the one or more environmentalclassifications.
 16. The apparatus of claim 14, wherein to generate theone or more body noise classifications, the processing unit isconfigured to: simultaneously generate two or more differentclassifications of the one or more body noises.
 17. (canceled) 18.(canceled)
 19. The apparatus of claim 14, further comprising: a memoryconfigured to store a plurality of predetermined tinnitus therapy maps,wherein to generate the actuator control signals, the processing unit isconfigured to select, based on the one or more body noiseclassifications, a first tinnitus therapy map from among the pluralityof predetermined tinnitus therapy maps.
 20. The apparatus of claim 14,wherein the one or more body noise classifications indicate a currentestimated behavior of the recipient.
 21. The apparatus of claim 14,wherein the processing unit is configured to receive a user input inresponse to delivery of the tinnitus therapy signals to the recipient,wherein the user input indicates a recipient adjustment to the tinnitustherapy signals, and wherein the processing unit is configured to adjustthe tinnitus therapy signals based on the user input.
 22. The apparatusof claim 21, wherein the processing unit is configured to perform anautomated adaption process to adjust, based on the user input, futuretinnitus therapy signals delivered to the recipient in the presence ofthe one or more body noise classifications.
 23. (canceled) 24.(canceled)
 25. (canceled)